US EPA updates Toxic Substances Control Act TSCA fees to improve chemical reviews

On February 8, 2024, the Environmental Protection Agency (EPA) finalized amendments to the 2018 Toxic Substances Control Act (TSCA) Fees Rule, which will increase fees and double the cost of new substance applications. The final rule aims to recover more program costs through industry-submitted fees. The agency cites the need for funding due to expanded TSCA responsibilities. Increased fees will increase resources for efficient chemicals, allowing for better protection of communities and supporting American innovation.

The final rule will become effective 60 days after its official publication in the Federal Register.

Key Changes

The final rule sets a fee of $37,000 for filing a Pre-Manufacture Notice (PMN) or Significant New Use Notice (SNUN), and $10,870 for filing a new chemicals exemption notice under TSCA Section 5. The EPA-initiated risk evaluation fee will increase from $1.605 million to $4.287 million which will be shared among responsible companies. Meanwhile, test orders will be priced at $25,000. Small businesses are eligible for an 80% fee reduction in each category. Some fees were reduced from the 2022 supplemental proposal due to adjustments in program costs.

Comparison to Previous Proposals 

• The final rule excludes extra fee categories proposed in 2021, such as filing a bona fide notice or Notice of Commencement (NOC) for new substance manufacturing.
• EPA maintains its approach of allocating risk evaluation fees based on production volume, with top producers covering 80% of the total fee.
• Despite suggestions for a REACH-like tonnage band system, the agency rejected it due to potential difficulties in estimating future manufacturers, resulting in a 25% program cost gap.
• EPA dismissed addressing the issue of 'free riders' entering the market after invoicing, acknowledging a competitive disadvantage for companies that already submitted fees. The agency plans to monitor this issue for potential inclusion in future TSCA fee rules.
• However, EPA is backing away from refunding fees to PMN submitters who withdraw before risk management, citing resource constraints and staff burden.

Exemptions

The new rule adds exemptions not included in the 2018 fee rules: 

(1) An exemption for research and development activities 

(2) An exemption for companies that manufacture less than 2,500 pounds (lbs) of a chemical subject to an EPA-initiated risk evaluation, or 1,100 lbs for TSCA Section 4 test rules.

(3) An exemption for manufacturers of chemical substances produced as non-isolated intermediates.

(4) Exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, manufactured as a by-product, or manufactured or imported as an impurity.

Companies that fall into the first three categories must certify to the agency that they meet the exemption criteria.